PQKClass II

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Cardiovascular · 21 CFR 870.1252

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

MDR events486All time

Recalls1All time

Registered firms8Currently listed

510(k) clearances7All time

Recent MDR events

486 adverse event reports on file

Event type breakdown

Malfunction268

Injury211

Death7

Most-reported manufacturers

Clearstream Technologies Ltd.315 Bard Peripheral Vascular, Inc.80 Avenu Medical72 Tva Medical, Inc.15 Unk2 Avenu Medical (formerly Caymus Medical)1 Unknown1

Recalls

1 recall events for this product code

Bard Peripheral Vascular Inc
TerminatedUnknown
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053,
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
Z-1637-2020 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

510(k) clearances

7 clearances for this product code